Relapsing-Remitting Multiple Sclerosis
Conditions
Keywords
RRMS, Relapsing Remitting, MS
Brief summary
The primary objective of the study was to measure the change in bladder function as measured by Urogenital Distress Inventory (UDI)-6 compared to baseline over 6 months of Tysabri treatment. Secondary objectives were to (i) measure change from baseline over 6 months of Tysabri treatment in the number of urinary incontinence episodes per participant per week, (ii) measure change from baseline over 6 months of Tysabri treatment in the number of micturitions per participant per day, (iii) measure change in The North American Research Committee on Multiple Sclerosis (NARCOMS) bladder/bowel subscale (PSB) scores from baseline over 6 months of Tysabri treatment and (iv) measure change in Incontinence Impact Questionnaire (IIQ)-7 scores from baseline over 6 months of Tysabri treatment.
Interventions
DRUGBG0002 (natalizumab)
Participants who are newly prescribed TYSABRI, but have not received their first infusion, will be invited to participate.
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Participants are eligible to be screened for this study if all of the following criteria are met: * Patient must meet all prescribing criteria for TYSABRI® and eligible for the TOUCH™ program. * If utilizing medications for symptoms of bladder dysfunction (such as incontinence, urgency etc), subjects will need to remain on a stable dose of medication(s) for at least one month prior to and for duration of study. * If utilizing medications that affect urinary output (e.g. anticholinergics, diuretics, etc.), subjects will need to remain on a stable dose of medication(s) for at least one month prior to study entry and for the duration of the study. * Able to provide written informed consent. * Patient must be willing to maintain current hydration habits and caffeine intake for the duration of the study. Participants will be selected for enrollment if all of the following criteria are met: * Screening Visit urinary incontinence defined as: \- Greater than or equal to 3 incontinence episodes per week or greater than or equal to 8 micturitions per day (both mean numbers). * Screening Visit score on the UDI-6 of more than or equal to 6. * Screening Visit EDSS 0 - 6.5 Key
Exclusion criteria
Candidates will be excluded from study screening if any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in bladder function as measured by UDI-6 compared to baseline over 6 months of TYSABRI treatment. | Baseline and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline over 6 months of TYSABRI treatment in the number of urinary incontinence episodes per participant per week. | Baseline and 6 months |
| Change from baseline over 6 months of TYSABRI treatment in the number of micturitions per participant per day. | Baseline and 6 months |
| Change in NARCOMS PSB scores from baseline over 6 months of TYSABRI treatment. | Baseline and 6 months |
| Change in IIQ-7 scores from baseline over 6 months of TYSABRI treatment. | Baseline and 6 months |
Outcome results
None listed